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NCT Number: NCT05768477

Different Treatments in Chronic Pain Patients.

The goal of this observational study is to compare different treatment options in a chronic pain population. The main questions it aims to answer are:

* What is the effectiveness of the different therapy options in the pain center of Sint-Lucas on outcomes related to pain and disability? * What are predictive factors for the different therapy options in the pain center of Sint-Lucas? Which factors predict improvement in pain related outcomes?

Participant data will be gathered as part of their routine care. They can be advised to 4 different treatment options:

* Consultations with the pain specialist * Interventions by the pain specialist (infiltrations, denervations) * Baxter therapy * Interdisciplinary treatment

Researchers will compare patients with different dominant pain mechanisms to see which treatment are most effective for which dominant pain mechanisms.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Nociplastic Pain Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ St Lucas

Ghent, 9000, Belgium

Location status: Recruiting

Location contact

Elise Cnockaert

CONTACT

[email protected]

Elise Cnockaert

PRINCIPAL_INVESTIGATOR

About this study

The aim of the present study is to describe the natural flow of the chronic pain patients at the pain center AZ Sint-Lucas. Patients will be examined before starting the therapy, and receive standardized questionnaires at several fixed time points (before, during, and after their therapy trajectory). Information about the present dominant pain mechanism will be gathered during the examination. The questionnaires will gather demographic data, information about the present dominant pain mechanism, psychosocial factors, catastrophizing, fear and avoidance, illness perceptions, fatigue and information about therapy success. During the examination, typical signs of a dominant nociplastic pain mechanism will be gathered. By processing the data of the questionnaires and the examination, knowledge about (1) the amount of patients with a dominant nociplastic pain mechanism at intake, (2) the treatment trajectory for a specific diagnosis, and (3) the prediction of the therapy effect and prognosis will be obtained.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults
  • Chronic pain patients
  • Dutch speaking, or good understanding

Exclusion criteria

  • Adults unable to give consent
  • Adults who do not understand Dutch

Treatment and study plan

consultation

Other

Consultation with the pain specialist, which might entail prescription of medication of vitamins.

Interventions

Procedure

Facet injections, nerve denervations, infiltrations, Qutenza, Spinal Cord Stimulation, Transcutaneous Electrical Nerve Stimulation

Baxter therapy

Drug

Ketamine or Linisol baxter therapy

Interdisciplinary therapy

Behavioral

Interdisciplinary therapy provided by the physiotherapist, psychologist and occupational therapist.

Primary outcomes

  1. Change in Pain disability from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    Pain Disability Index, ranges from zero to 70, with a higher score indicating more pain-related disability

  2. Change in Pain intensity from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    Numeric Rating Scale for pain intensity in the past week, ranges from zero to 100, with a higher score indicating a higher pain intensity

  3. Change in Pain Frequency from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    Questions

  4. Change in Functionality from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    Patient Specific Complaints questionnaire, using a Numeric Rating Scale, ranging from zero to 100, with a higher score indicating a higher amount of functional disability

  5. Change in Quality of Life from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    EuroQol-5D questionnaire

Secondary outcomes

  1. Change in Post exertional malaise from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    Questions based on the criteria for Chronic Fatigue Syndrome.

  2. Change in Quality of Life from baseline until 18 months

    Time frame: 0 weeks, 4 weeks, 10 weeks, 6 months, 12 months, 18 months

    EuroQol - 5D, five questions about health range from one to three with a higher score indicating more difficulties. One question about perceived health ranges from zero to 100 with a higher score indicating better health.

Study contacts

Contact information is provided by the study sponsor or research team.

Elise Cnockaert

CONTACT

[email protected]

+32 9 332 56 35

Jessica Van Oosterwijck, Professor

CONTACT

[email protected]

+32 9 332 69 19

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

Research of the Different Treatments for Chronic Pain Patients, Their Effectiveness and Associated Predictors, Offered at the Pain Center AZ Sint-Lucas Ghent.

Acronym: EC_PC_AZSTL

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 14, 2023
Registry last updated
Jun 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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